{Reference Type}: Journal Article
{Title}: Flotetuzumab as a salvage immunotherapy in advanced CD123-positive hematological malignancies, a phase 1 pilot study.
{Author}: Aldoss I;Zhang J;Robbins M;Song J;Al Malki MM;Otoukesh S;Sandhu K;Agrawal V;Herrera AF;Popplewell LL;Ghoda L;Stein A;Marcucci G;Forman S;Pullarkat V;
{Journal}: Leuk Lymphoma
{Volume}: 65
{Issue}: 8
{Year}: 2024 Aug 17
暂无{DOI}: 10.1080/10428194.2024.2343029
{Abstract}: CD123 "expression" is common in hematological malignancies, including acute lymphoblastic leukemia (ALL). Flotetuzumab is a novel, investigational CD3/CD123 DART®. We conducted a phase 1 study evaluating safety and efficacy of flotetuzumab in relapsed/refractory ALL (Cohort A) and other advanced CD123-positive hematological malignancies (excluding myeloid malignancies) (cohort B). Thirteen patients (9 in Cohort A and 4 in Cohort B) were treated at dose level 1 (500 ng/kg/day) before early closure due to discontinuation of drug development by sponsor. Two dose limiting toxicities (Grade 4 thrombocytopenia and neutropenia) occurred in one patient in Cohort B. Cytokine release syndrome occurred in most patients (85%), all being grade ≤2. Responses only occurred in Cohort B, with a partial response in one patient with Hodgkin's lymphoma and morphological complete remission in the bone marrow in one patient with blastic plasmacytoid dendritic cell neoplasm. In conclusion, flotetuzumab had a manageable safety profile in advanced CD123-positive hematological malignancies.